Microbiome Therapeutics Innovation Group

What Microbiome Therapeutics Innovation Group does

Microbiome Therapeutics Innovation Group (MTIG) is an independent 501(c)(6) nonprofit coalition headquartered in Washington, D.C., founded in 2017 and publicly launched in August 2018. The organization aggregates pharmaceutical and biotechnology companies pursuing FDA-approved microbiome therapeutics—including Rebiotix, Seres Therapeutics, Nestlé Health Science, Vedanta Biosciences, MaaT Pharma, Microba Life Sciences, Siolta Therapeutics, BiomeSense, Biose Industrie, Freya Biosciences, Alveolus Bio, and Genetic Analysis—into a unified advocacy voice on regulatory and commercial policy. MTIG does not develop or commercialize therapeutic products itself; rather, its core function is to engage FDA, CMS, and Congress on issues including clinical trial design, endpoint and biomarker selection, expedited review pathways, product nomenclature, and enforcement discretion around fecal microbiota transplantation. Operational management is outsourced to The Conafay Group, a Washington-based life sciences government relations firm, while regulatory counsel is provided by Paul Kim of Kendall Square Strategies, a former Deputy Staff Director for health policy for Senator Edward M. Kennedy.

MTIG's value proposition rests on collective regulatory influence exceeding what any individual member company could achieve independently. The coalition's advocacy contributed to two landmark FDA approvals for member products—Rebiotix's REBYOTA in November 2022 (the first microbiota-based live biotherapeutic for recurrent C. difficile infection) and Seres Therapeutics' VOWST in April 2023 (the first FDA-approved oral live biotherapeutic). In August 2025, MTIG escalated its regulatory posture by filing a Citizen Petition urging FDA to revise its 2022 FMT enforcement discretion guidance and close the IND-loophole.

MTIG operates a membership-based business model with undisclosed dues and no public revenue disclosure. Headcount is 1-10 employees, and member onboarding has occurred consistently from 2021 through 2026, most recently with Nestlé Health Science in April 2026. International footprint is limited to a September 2024 collaboration agreement with the European Microbiome Innovation for Health (EMIH) covering the EU, UK, and Switzerland. The organization distributes policy positions through its website, PR Newswire press releases, and industry conference participation rather than commercial product channels.

Name

Microbiome Therapeutics Innovation Group

Legal name

Microbiome Therapeutics Innovation Group

Website

https://microbiometig.org

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

Microbiome Therapeutics Innovation Group (MTIG) is a 501(c)(6) nonprofit coalition of 11+ pharmaceutical and biotechnology companies that advocates for regulatory clarity, FDA guidance, and policy advancement for FDA-approved microbiome therapeutics, operating out of Washington, D.C. via The Conafay Group.

Ownership category

akta.pro rank

Headquarters

HQ city

Washington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Distribution channels1 record

Marketing channels4 records

Core offering

MTIG is a 501(c)(6) nonprofit coalition that provides collective regulatory advocacy, policy development, and stakeholder education services to pharmaceutical and biotechnology companies pursuing FDA-approved microbiome therapeutics. It functions as a unified industry voice engaging with the FDA, CMS, and Congress to accelerate product development, harmonize regulatory frameworks, and expand patient access to approved microbiome therapies.

Product overview

MTIG is a coalition/advocacy organization (not a product company) focused on advancing FDA-approved microbiome therapeutics and microbiome-based products. The organization works to enhance regulatory, investment, and commercial environments for its member companies including Rebiotix, Seres Therapeutics, Nestlé Health Science, Vedanta Biosciences, Siolta Therapeutics, MaaT Pharma, Microba Life Sciences, Genetic Analysis, BiomeSense, Biose Industrie, Freya Biosciences, and Alveolus Bio. The coalition's activities include regulatory advocacy, policy development, and stakeholder collaboration rather than product development or sales.

Differentiator

Problem solved

Functional benefit

Products and services

• MTIG Coalition Membership Membership-based participation in a 501(c)(6) coalition of companies pursuing FDA-approved microbiome therapeutics; provides collective regulatory advocacy, FDA and Congressional engagement, clinical trial design guidance, and stakeholder education. Available to pharmaceutical and biotechnology companies pursuing regulatory approvals for microbiome therapeutics and microbiome-based products.

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Four partnerships are on record, tiered core.

• Nestlé Health SciencecoreStrategic or Co-development Partner · 29 April 2026Nestlé Health Science joined MTIG as a member company. As part of the membership, Krys Araujo-Torres, MD, MPP, Global Head of Medical, Science, Regulatory Organization at Nestlé Health Science, serves as Nestlé's primary representative within the coalition. Nestlé, in collaboration with Seres Therapeutics, brought VOWST to market—the first and only FDA-approved oral live biotherapeutic product for prevention of recurrent C. difficile infection.
• European Microbiome Innovation for Health (EMIH)coreStrategic or Co-development Partner · 23 September 2024MTIG and EMIH announced a collaboration agreement to advance microbiome drug development, explore synergies between international regulators, and convene cross-continental meetings. A main priority is harmonizing regulatory frameworks from multiple regions to create a cohesive approach in seeking policy and regulatory solutions for microbiome drug developers. EMIH represents innovative microbiome companies across the EU, UK, and Switzerland.
• The Conafay GroupcoreImplementation/ SI/ Consulting PartnerThe Conafay Group serves as Washington counsel and coalition manager for MTIG. The life-sciences government relations firm based in Washington D.C. specializes in representing life sciences companies before the federal government and associated stakeholders.
• Kendall Square StrategiescoreImplementation/ SI/ Consulting PartnerPaul Kim, Partner at Kendall Square Strategies, serves as MTIG Regulatory Counsel. He is regarded as one of the top food and drug lawyers in Washington, drawing on extensive governmental experience to advise clients on legal, legislative, and regulatory issues in food, drug and device law.

Scale indicators7 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Alliance for Regenerative Medicine (ARM): Industry coalition advocating for regulatory, reimbursement, and commercial frameworks for cell and gene therapies. Operates with an analogous 501(c)(6) coalition model focused on accelerating an emerging therapeutic modality through FDA engagement and policy shaping - structurally identical to MTIG's playbook for microbiome therapeutics.
• Personalized Medicine Coalition (PMC): 501(c)(3) education and advocacy organization advancing personalized/precision medicine. Shares MTIG's emphasis on biomarker-driven clinical trial design, regulatory pathway clarity, and FDA engagement, though PMC operates as an education-focused nonprofit rather than a 501(c)(6) business league.
• European Microbiome Innovation for Health (EMIH): European counterpart coalition of innovative microbiome companies across the EU, UK, and Switzerland. MTIG's existing cross-Atlantic collaboration agreement with EMIH is explicitly aimed at harmonizing regulatory frameworks, demonstrating identical mission and structure on a different geography.

Others

• FasterCures: Milken Institute center focused on accelerating medical research and therapeutic development through policy and patient-engagement advocacy. Operates adjacent to MTIG by championing accelerated patient access pathways and improved regulatory frameworks relevant to emerging therapeutic classes.
• Council of State Bioscience Associations (CSBA): Umbrella network of U.S. state-level bioscience trade associations. Functions as a coordination layer for trade associations including influencing FDA-adjacent state-level policy, complementing rather than competing with MTIG.
• International Society for Pharmaceutical Engineering (ISPE): Member-driven organization advancing pharmaceutical manufacturing standards and compliance. Shares MTIG's trade-association structure and pharmaceutical industry adjacency, but focused on manufacturing quality rather than therapeutic-area regulatory policy.
• RxBenefits / National Council for Prescription Drug Programs (NCPDP): Standards-setting organization for pharmacy and prescription drug benefit infrastructure. Comparable as a healthcare coalition creating interoperability and policy frameworks, but focused on pharmacy-benefit administration rather than microbiome therapeutic approval.
• Drug Information Association (DIA): Global neutral forum for life sciences R&D professionals across regulatory, clinical, and biopharmaceutical disciplines. Provides educational forums MTIG members participate in (e.g., IDWeek adjacent events), but operates as a neutral convener rather than an industry advocacy voice.

Broad incumbents

• Biotechnology Innovation Organization (BIO): Largest U.S. biotechnology industry trade association, representing 1,000+ member companies across all biotech subsectors. Comparable as a broad membership advocacy organization influencing FDA policy, but operates at much larger scale and lacks MTIG's narrow microbiome focus.
• Pharmaceutical Research and Manufacturers of America (PhRMA): U.S. pharmaceutical industry trade association representing major drug companies. Stephen Conafay, MTIG's Washington Counsel, previously served as EVP at PhRMA, signaling a direct institutional lineage. Comparable as a deep FDA/Congress advocacy organization, but vastly broader in scope.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/mtig_news
• Facebookfacebook.com/MTIGNews
• LinkedInlinkedin.com/company/microbiome-therapeutics-innovation-group

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Microbiome Therapeutics Innovation Group